Novella Clinical, Inc. "formerly known as PharmaLinkFHI"

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Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Employees

Employee
Years
Job
Industry
Gwyndolyn Carver Gwyndolyn Carver Raleigh-Durham, North Carolina Area Details
Gwyndolyn Carver's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience February 2009 - February 2010
Job Clinical Safety Professional
Industry Pharmaceuticals
Experience
Drug Safety Alliance Ashfield Pharmacovigilance  May 2015 - Present
PPD  December 2014 - April 2015
Theorem Clinical Research  August 2014 - November 2014
Drug Safety Alliance, Inc.   October 2013 - August 2014
Duke University Medical Center - Duke Cancer Institute   December 2012 - March 2013
Drug Safety Alliance  October 2012 - December 2012
Quintiles  November 2011 - June 2012
Independent Contractor  August 2010 - November 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   February 2009 - February 2010
Health Decisions  April 2008 - December 2008

Skills
Drug Safety, Clinical Monitoring, CRO, Clinical Trials, EDC, GCP, Inform, Oncology, FDA, Clinical Research, Protocol, Data Management, SOP, MedDRA, CTMS

Education
North Carolina Agricultural and Technical State University   1989 — 1995
Bachelor of Science (B.Sc.), Food Science

Susie Jasso Susie Jasso Greater Denver Area Details
Susie Jasso's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience September 2010 - July 2011
Job Senior Clinical Data Manager
Industry Research
Experience
Wincere, Inc as Gilead Contractor   October 2013 - March 2014
Array BioPharma  August 2011 - August 2013
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   September 2010 - July 2011
INC Research  July 2009 - September 2010
Allos Therapeutics, Inc  July 2008 - July 2009
etrials Worldwide, Inc   2007 - 2008
INC Research  2005 - 2007

Skills
EDC, CRO, Clinical Trials, Clinical Data Management, 21 CFR Part 11, Oncology, GCP, CRF design, Oracle Clinical, Clinical Research, ICH-GCP, CTMS, Data Management, Clinical Development, Medidata, FDA, Protocol, Hematology, Validation, MedDRA, Inform

Education
University of North Carolina at Chapel Hill   1995 — 1999
Bachelor of Science in Biology

Rachael Geedey Rachael Geedey Raleigh-Durham, North Carolina Area Details
Rachael Geedey's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience July 2008 - July 2009
Job Application Trainer I at Novella Clinical
Industry Pharmaceuticals
Experience
Novella Clinical  November 2013 - Present
Novella Clinical, Inc.   July 2009 - October 2013
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   July 2008 - July 2009
Accentuate Staffing  June 2006 - June 2008
Ruthi Postow Staffing  June 2005 - June 2006

Skills
CRO, CTMS, EDC, Clinical Trials, Clinical Research, Training, GCP, Human Resources, Pharmaceutical Industry, Clinical Development, ICH-GCP, Sop, Clinical Monitoring, Clinical Data Management, Software Documentation, Management, Oncology, SOP

Education
University of North Carolina at Chapel Hill   2001 — 2005
BA, Communication Studies

North Mecklenburg High School   1998 — 2001

Amy Moon Amy Moon Raleigh-Durham, North Carolina Area Details
Amy Moon's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience July 2009 - December 2011
Job Safety Manager at Chimerix, Inc.
Industry Research
Experience
Chimerix, Inc.   April 2015 - Present
Salix Pharmaceuticals  June 2012 - April 2015
Novella Clinical, Inc.   December 2011 - July 2012
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   July 2009 - December 2011
PAREXEL  2008 - 2009
Duke Clinical Research Institute  October 2004 - December 2008
Duke University Medical Center  2001 - 2004

Skills
Clinical Research

Education
Duquesne University   1994 — 1998
BSN, Nursing

Danny Harris, MIS Danny Harris, MIS Annapolis, Maryland Details
Danny Harris, MIS's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience January 2010 - August 2010
Job Amerigroup
Industry Insurance
Experience
Amerigroup  August 2014 - August 2015
Quintiles  October 2011 - August 2014
Vistronix, Inc.   October 2010 - October 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   January 2010 - August 2010
I3 United Healthcare   June 2009 - December 2009
Novartis Animal Health  May 2007 - June 2009
Syngenta Biotechnology, Research   July 2005 - May 2007
Eli Lilly, Research   July 2001 - December 2004
Amplistar Inc   January 2001 - April 2001
Wyeth Pharmaceutical  November 2000 - December 2000

Skills
Validation, SOP, Data Analysis, SQL, Problem Solving, Quality Assurance, Documentation, Clinical, GLP, Research, Databases, Biotechnology, Windows, Pharmaceuticals, Sop, GCP, Software Documentation, Regulatory Affairs, Clinical Development, FDA, Clinical Trials, GMP, LIMS, CTMS, Process Improvement, Pharmaceutical Industry

Education
Drexel University   2010 — 2012
MBA, Pharmaceutical Business

North Carolina Central University   2003 — 2006
Master, Information Systems

University of North Carolina at Chapel Hill   2002 — 2003
Business/MIS

Winston-Salem State University   1994 — 1996
BS, Applied Science

Appalachian State University
BIOLOGY, BUSINESS

North Carolina Agricultural and Technical State University

Janna Christy-Bittel Janna Christy-Bittel Greater Denver Area Details
Janna Christy-Bittel's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience February 2010 - June 2010
Job Clinical Development
Industry Pharmaceuticals
Experience
Array BioPharma  July 2010 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   February 2010 - June 2010
OSI Pharmaceuticals  March 2009 - January 2010
OSI Pharmaceuticals  January 2001 - March 2009
Gilead Sciences  September 2000 - December 2001
Marion Laboratories  1987 - 1999

Skills
Oncology, Medicine, Clinical Trials, Clinical Development, CRO, Pharmaceutical Industry, Hematology, Drug Development, Clinical Research, Biotechnology, GCP, CTMS, Therapeutic Areas, EDC, Clinical Monitoring, Pharmacology, Clinical Data Management, Regulatory Submissions, Infectious Diseases, Medical Writing, ICH-GCP, Protocol, Regulatory Affairs, Immunology, Cancer, Sop, Clinical Operations, FDA, Medical Affairs, Drug Discovery, Clinical Pharmacology, Biomarkers, IND, Translational Medicine, Lifesciences, Pharmacokinetics, Pharmacovigilance, Biopharmaceuticals, Diabetes, GLP, Cardiology, Endocrinology, Pharmacodynamics, Phase I, Clinical Study Design, Neurology, Toxicology, Vaccines, Drug Metabolism

Education
The University of Kansas   1991 — 1993
MSN, Oncology Nursing

University of Kansas   1972 — 1977
MS, Oncology Nursing

Josh Jarrell Josh Jarrell Raleigh-Durham, North Carolina Area Details
Josh Jarrell's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience November 2007 - February 2008
Job CTM II at PRA
Industry Pharmaceuticals
Experience
PRA International  October 2012 - Present
Novella Clinical, Inc.   February 2008 - October 2012
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   November 2007 - February 2008
PPD  April 2006 - November 2007
PPD  April 2005 - April 2006
PPD  March 2004 - April 2005
PPD  June 1999 - November 2002

Skills
Clinical Data Management, CRO, EDC, Clinical Monitoring, CTMS, Clinical Research, GCP

Education
Campbell University   2000 — 2003
BBA, Business

Siechieh Redd Siechieh Redd Raleigh-Durham, North Carolina Area Details
Siechieh Redd's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience 2010 - April 2011
Job Global Project Manager at Acer Pharmaceutical Group
Industry Research
Experience
Acer Pharmaceutical Group   2011 - Present
PSI Pharma Support Intl  2010 - 2013
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   2010 - April 2011
i3 Research  May 2009 - July 2010
Alpharma  2006 - 2009

Skills
Biotechnology, CRO, CTMS, Clinical Development, Clinical Monitoring, Clinical Research, Clinical Trials, Data Management, EDC, FDA, GCP, ICH-GCP, Lifesciences, Management, Medical Devices, Oncology, Pharmaceutical Industry, Project Management, Quality Assurance, Sop, Therapeutic Areas, Life Sciences

Education
Pfeiffer University   2007 — 2010
MBA/MHA

North Carolina State University   1996 — 2000

Christa Agee Christa Agee Raleigh-Durham, North Carolina Area Details
Christa Agee's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience February 2006 - April 2007
Job Sr. Clinical Site Associate at Novella Clinical, Inc.
Industry Research
Experience
Novella Clinical, Inc.   January 2013 - Present
Novella Clinical, Inc.   April 2007 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   February 2006 - April 2007
Lineberger Comprehensive Cancer Center UNC Oncology Protocol Office   October 2002 - February 2006
UNC Hospitals  October 2000 - October 2002

Skills
Oncology, Inform, Cardiology, Diabetes, EDC, CTMS, Medical Devices, Clinical Research, Clinical Monitoring, FDA, Clinical Trials, CRO, GCP, Protocol, Software Documentation, Sop, CRF design, Trial Management, Clinical Data Management, Clinical Study Design, ICH-GCP, Therapeutic Areas, SOP

Education
Iona College   1989 — 1991
LPN, Nursing

Leslie Parks Leslie Parks United States Details
Leslie Parks's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience March 2005 - March 2007
Job Proposal Analyst at Novella Clinical, Inc.
Industry Pharmaceuticals
Experience
Novella Clinical, Inc.   August 2014 - Present
Novella Clinical Resourcing  January 2008 - August 2014
Novella Clinical Inc.  June 2006 - January 2008
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   March 2005 - March 2007
Novella Clinical Inc.  April 2004 - March 2005

Skills
CRO, GCP, EDC, Oncology, Pharmaceutical Industry, Clinical Trials, Quality Assurance, Clinical Development, Clinical Monitoring, Regulatory Affairs, CTMS, ICH-GCP, Clinical Data Management, Sop, Regulatory Submissions, FDA, Clinical Operations, Therapeutic Areas, SOP

Education
National Paralegal College   2011 — 2013
Certificate in Paralegal Studies, Paralegal Studies

Michigan State University   1989 — 1991

Shirley Ellis Peele Shirley Ellis Peele Wilmington, North Carolina Area Details
Shirley Ellis Peele's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience June 2010 - July 2011
Job Data Management Project Lead at Chiltern International
Industry Pharmaceuticals
Experience
Chiltern International  August 2013 - Present
INC Research  August 2011 - August 2013
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   June 2010 - July 2011
Quintiles  November 2008 - June 2010
PAREXEL  January 2007 - November 2008
Westat  2006 - 2007
Duke Clinical Research Institute  1997 - 2001

Skills
Oracle Clinical, EDC, GCP, Clinical Data Management, Inform, CDISC, Clinical Trials, Data Management, CRO, CTMS, Medidata, ICH-GCP, CRF design, Biostatistics, SDTM

Education
North Carolina Central University   2002 — 2005
Health Education

Elizabeth Colacino Elizabeth Colacino Greater New York City Area Details
Elizabeth Colacino's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience August 2010 - Present
Job Clinical Research Monitor
Industry Pharmaceuticals
Experience
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   August 2010 - Present
Bausch & Lomb  January 2003 - Present
eReady Monitors   November 2007 - February 2008
PTC Therapeutics  2005 - 2008

Skills
CRO, CTMS, GCP, Oncology, Ophthalmology, Pharmacovigilance, Clinical Trials, Clinical Monitoring, FDA, EDC, Pharmaceutical Industry, Drug Development, Protocol writing, Clinical SOPs, Clinical Research, Therapeutic Areas, Clinical Data Management, ICH-GCP, Protocol, Clinical Development, Inform, Infectious Diseases, Clinical Operations, Medical Writing, Regulatory Affairs

Education
University of North Carolina at Chapel Hill
MS, Bacteriology, Immunology

Schuyler Thorne Schuyler Thorne Greater Denver Area Details
Schuyler Thorne's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience August 2010 - August 2011
Job Senior Systems Engineer at CoreSite
Industry Information Technology and Services
Experience
CoreSite  February 2014 - Present
CoreSite  December 2012 - February 2014
CoreSite  August 2011 - December 2012
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   August 2010 - August 2011
OSI Pharmaceuticals  March 2005 - September 2010
eCollege.com  January 2004 - March 2005

Skills
Disaster Recovery, Active Directory, VMware, Troubleshooting, Cisco Technologies, Microsoft Exchange, Security, Hardware, Technical Support, Blackberry Enterprise..., Software Installation, Windows, Storage, Laptops, Help Desk Support, System Deployment, Hyper-V, Printers, LAN-WAN, Databases, Data Center, TCP/IP, Virtualization, VPN

Education
Colorado State University   1997 — 2001
Computer Information Systems, Business

Chloe Katz Chloe Katz Raleigh-Durham, North Carolina Area Details
Chloe Katz's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience February 2010 - June 2010
Job Associate Project Manager at Social & Scientific Systems
Industry Research
Experience
Social & Scientific Systems  July 2013 - Present
SRA International  September 2010 - Present
Family Health International  January 2009 - September 2010
fhi  January 2009 - September 2010
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   February 2010 - June 2010
North Carolina Institute for Public Health  May 2008 - January 2009
SRA International, formerly Constella Group, LLC   September 2006 - August 2007
Family Health International  September 2005 - September 2006
United States Peace Corps  January 2003 - April 2005

Skills
Public Health, Clinical Trials, Clinical Research, Qualitative Research, Data Management, Research, Software Documentation, Epidemiology, Analysis, Project Management

Education
The George Washington University School of Medicine and Health Sciences   2010 — 2014
MSHS, Clinical Research Administration

University of North Carolina at Chapel Hill   2007 — 2009
MPH, Public Health

University of California, Santa Cruz   1997 — 2001
BA, French

Beverly Bell Beverly Bell Raleigh-Durham, North Carolina Area Details
Beverly Bell's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience 2004 - 2005
Job Project Manager Research and Development at Merz Pharmaceuticals, LLC
Industry Pharmaceuticals
Experience
Merz North America, Inc.   September 2012 - Present
ClinDev Consulting, LLC   2001 - Present
Otsuka Pharmaceutical Development and Commercialization  March 2011 - August 2012
Cardioxyl Pharmaceuticals   December 2009 - March 2011
BioCryst Pharmaceuticals  2009 - 2009
Roche Kforce Alliance   2005 - 2008
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   2004 - 2005
Family Health International  2002 - 2005
Triangle Pharmaceuticals  1998 - 2002
ClinTrials Research  1996 - 1998

Skills
Clinical Research, Clinical Trials, Clinical Trial..., Clinical Development, SOP, Protocol Development, Cardiology, Infectious Diseases, Medical Devices, CTMS, Clinical Monitoring, Clinical Study Design, CRO, Vaccines, Pharmaceutical Industry, Oncology, Drug Development, ICH-GCP, EDC, GCP, Therapeutic Areas, Regulatory Affairs, Regulatory Submissions, FDA, Protocol, Clinical Data Management, 21 CFR Part 11, Diabetes

Education
Pfeiffer University   1995 — 1998
MBA, MHA, Business and Health Administration

Guilford Technical Community College
AAS, Dental Hygiene

High Point University
BA, Industrial Organization Psychology

Mark Weadon II, CPA Mark Weadon II, CPA Raleigh-Durham, North Carolina Area Details
Mark Weadon II, CPA's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience June 2009 - April 2010
Job Audit Senior Associate at Dixon Hughes Goodman LLP
Industry Accounting
Experience
Dixon Hughes Goodman LLP  June 2010 - August 2010
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   June 2009 - April 2010
PPD  June 2007 - June 2009

Education
North Carolina State University - College of Management   2010 — 2011
Masters of Accounting

North Carolina State University - College of Management   2007 — 2009
BS - Cum Laude - Business Management, Finance and Accounting

Methodist University   2005 — 2007
Finance and Accounting

Chi Vu Donaldson Chi Vu Donaldson Raleigh-Durham, North Carolina Area Details
Chi Vu Donaldson's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience February 2010 - May 2011
Job Project Coordinator at inVentiv Health Clinical
Industry Research
Experience
inVentiv Health Clinical  November 2014 - Present
inVentiv Health Clinical  November 2014 - Present
FHI 360  June 2014 - September 2014
Family Health International 360   February 2009 - May 2014
inventiv health clinical  2014 - 2014
inventiv health clinical  2014 - 2014
inventiv health clinical  2014 - 2014
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   February 2010 - May 2011
Polaris Compliance Consultants, Inc "formerly known as Polaris Clinical Research Consultants"   May 2008 - November 2008
Health Decisions  2008 - 2008

Skills
Clinical Trials, Clinical Data Management, Clinical Research, Sop, FDA, GCP, 21 CFR Part 11, Cross-functional Team..., Clinical Study Design, Data Management, Regulatory Affairs, Biotechnology, CTMS, Oncology, Clinical Monitoring, SOP

Education
Society of Clinical Research Associates   2008 — 2015
Certificate, Clinical Research - CCRP -

Durham Technical Community College   2006 — 2008
A.A.S, Clinical Trial Reseach Associate

California Polytechnic State University-San Luis Obispo   1995 — 1999
BS, Computer Engineering

Le Hong Phong Highschool

Janelle J Branch Janelle J Branch Raleigh-Durham, North Carolina Area Details
Janelle J Branch's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience 2009 - 2010
Job Clincal Trial Assistant II at Duke Clinical Research Institute
Industry Pharmaceuticals
Experience
Duke Clinical Research Institute  October 2010 - Present
UCB Pharma  2010 - 2010
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   2009 - 2010
Quintiles  2006 - 2009
PPD  2006 - 2006

Skills
Inform, EDC, GCP, Therapeutic areas, Clinical Research, Regulatory Reporting, Drug Safety, Medidata, SharePoint, Clintrace, Oracle AERS, ARISg, Intralinks, Share Web, Clinical Trials, Clinical Events..., MS Office Suite

Education
North Carolina Agricultural and Technical State University   2001 — 2005
Bachelors of Art, English

Southeast Raleigh High School

Southeast Raleigh High School

Michelle Foltz Michelle Foltz Raleigh-Durham, North Carolina Area Details
Michelle Foltz's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience October 2005 - February 2011
Job Director, SIA Team Management at PPD
Industry Research
Experience
PPD  July 2013 - Present
Novella Clinical  December 2011 - July 2013
Novella Clinical, Inc.   February 2011 - December 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   October 2005 - February 2011
PPD  2001 - 2005
PPD  1999 - 2001
PPD  1990 - 1998

Skills
Clinical Research, Leadership, FDA, CTMS, Clinical Monitoring, EDC, Clinical Trials, Project Management, Clinical Development, CRO, Training, Vaccines, GCP, Therapeutic Areas, Clinical Operations, ICH-GCP, Oncology

Education
University of North Carolina at Wilmington   1984 — 1988
BS, Biology

Megan (Honeycutt) Grissom Megan (Honeycutt) Grissom Wilmington, North Carolina Area Details
Megan (Honeycutt) Grissom's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience March 2010 - January 2011
Job Clinical Research Associate
Industry Pharmaceuticals
Experience
INC Research  June 2015 - Present
INC Research  February 2014 - May 2015
Quintiles  July 2012 - February 2014
Quintiles  January 2012 - July 2012
Novella Clinical, Inc.   January 2011 - January 2012
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   March 2010 - January 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   January 2010 - March 2010
Healthwise Pharmacy   September 2008 - November 2009

Skills
CTMS, Therapeutic Area, Clinical Trials, Multiple Myeloma, Infectious Diseases, Analysis, CRO, Clinical Development, Clinical Data Management, Clinical Research, Clinical Operations, Clinical Monitoring, EDC, Clinical Study Design, ICH-GCP, GCP, Management, IRB, Pharmaceutical Industry, Oncology, Project Management, Software Documentation, Therapeutic Areas

Education
East Carolina University   2006 — 2010
BS, Health Services Management

Heather Hamling Heather Hamling Raleigh-Durham, North Carolina Area Details
Heather Hamling's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience October 2010 - March 2011
Job Senior SIA Team Manager, Site Intelligence & Activation
Industry Pharmaceuticals
Experience
PPD  September 2014 - Present
DST Health Solutions  April 2014 - September 2014
Novella Clinical, Inc.   April 2013 - April 2014
Novella Clinical, Inc.   March 2011 - April 2013
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   October 2010 - March 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   April 2009 - October 2010
RTI Health Solutions  April 2007 - April 2009

Skills
Clinical Trials, CTMS, GCP, EDC, CRO, Clinical Development, Oncology, Clinical Research, ICH-GCP, Pharmaceutical Industry, Inform, Sop, Infectious Diseases, Regulatory Affairs, Pharmacovigilance, Cardiology, Diabetes, Biotechnology, Clinical Operations, Medical Devices, Vaccines, Drug Safety, 21 CFR Part 11, Drug Development, Regulatory Requirements, Gastroenterology, FDA, Protocol

Education
The George Washington University School of Medicine and Health Sciences   2009 — 2011
MSHS, Clinical Research

William & Mary   1998 — 2002
BA, Anthropology, History

John Nicosia John Nicosia Durham, North Carolina Details
John Nicosia's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience September 2002 - December 2002
Job Head Site and Patient Channel Management
Industry Pharmaceuticals
Experience
Quintiles  January 2015 - Present
Quintiles  March 2013 - Present
Quintiles  March 2011 - Present
Quintiles  March 2009 - March 2011
Quintiles  January 2006 - March 2009
Quintiles  December 2003 - December 2006
Verispan  January 2003 - December 2003
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   September 2002 - December 2002
Quintiles  September 2000 - September 2002
Quintiles  January 1999 - September 2000

Skills
Account Management, Business Development, Intranet, Marketing, Cold Calling, Lead Generation, CRO, Metadata Management, Clinical Trials, Laboratory, Business Communications, Project Management, Project Planning, Problem Solving, Collaboration, Proposal Writing, Proposal Generation, Proposal Support, Sales Operations, Salesforce.com, Microsoft Office, Clinical Research, Cross-functional..., Closing Deals, Closing Business, Clinical Monitoring, Oncology, CTMS, ICH-GCP, Clinical Data Management, Therapeutic Areas, Pharmaceutical Industry, EDC, Biotechnology, Clinical Development, Cross-functional Team..., GCP, Cardiology, FDA, Biopharmaceuticals, Deal Closure, Life Sciences, Management, Drug Development, SOP, Infectious Diseases

Education
North Carolina State University   1992 — 1996
Forest Management, Forestry, Natural Resources, Mapping

Sanderson Highschool   1988 — 1992
Diploma, Popularity and Band Camp

Katy Mulleady Katy Mulleady Boise, Idaho Area Details
Katy Mulleady's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience August 2008 - August 2009
Job Associate Global Regulatory and Start Up Director at Quintiles
Industry Pharmaceuticals
Experience
Quintiles  October 2014 - Present
Quintiles  June 2012 - October 2014
Novella Clinical, Inc.   May 2011 - May 2012
i3 Research  February 2011 - May 2011
i3 Research  August 2009 - February 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   August 2008 - August 2009
i3 Research  August 2007 - August 2008
PPD  January 2005 - August 2007
Integrated Laboratory Systems  January 2004 - January 2005

Skills
Clinical Trials, CRO, GCP, CTMS, Pharmaceutical Industry, Clinical Development, EDC, ICH-GCP, Oncology, Regulatory Affairs

Education
Durham Technical Community College   2004 — 2005
Certificate, Clinical Research

Greensboro College   1999 — 2003
BS, Biology, Chemistry, Religion

Molly James Molly James Raleigh-Durham, North Carolina Area Details
Molly James's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience January 2009 - May 2010
Job Vice President, Global Safety Operations at Drug Safety Navigator, LLC
Industry Pharmaceuticals
Experience
Drug Safety Navigator, LLC   January 2015 - Present
Five Oaks Pharm, LLC   September 2011 - January 2015
Inspire  May 2010 - September 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   January 2009 - May 2010
UCB Pharma  2007 - 2009
Drug Safety Alliance  July 2006 - September 2007
PPD  2002 - 2006

Skills
Clinical Trials, CRO, Clinical Research, Pharmacovigilance, ICH-GCP, Drug Safety, EDC, Sop, CTMS, Pharmaceutics, Biotechnology, Regulatory Requirements, Oncology, Clinical Development, GCP, SOP

Education
University of Michigan   1982 — 1986
BSN, Nursing

Tiffany Blakeney, J.D., PhD. Tiffany Blakeney, J.D., PhD. Raleigh-Durham, North Carolina Area Details
Tiffany Blakeney, J.D., PhD.'s Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience June 2003 - June 2004
Job Corporate CRA Lead CRA at ICON
Industry Biotechnology
Experience
The EMMES Corporation  November 2010 - August 2011
Clinical PRofessionals Network   2009 - 2011
Clinsys Clinical Research  March 2008 - March 2010
COVANCE INCORPORATED   March 2007 - February 2008
Kendle International  December 2005 - February 2007
Chiltern International  June 2004 - November 2005
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   June 2003 - June 2004
Phoenix Data Systems  October 2002 - June 2003
Bayer CropScience  March 2002 - October 2002
PAREXEL - CONTRACT   December 2000 - February 2002

Education
Villanova University

UNIVERSITY OF NORTH CAROLINA

North Carolina Central University   1987 — 1991
B.A., Political Science (minor) Life Sciences

Adrian Johnson Adrian Johnson Raleigh-Durham, North Carolina Area Details
Adrian Johnson's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience July 2009 - November 2010
Job Pharmacovilance Manager at United Therapeutics
Industry Biotechnology
Experience
United Therapeutics  September 2013 - Present
United Therapeutics  September 2012 - September 2013
Drug Safety Alliance  October 2011 - September 2012
United Therapeutics  November 2010 - May 2011
Otsuka America Pharmaceutical, Inc.   2011 - 2011
Abbott Laboratories  2011 - 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   July 2009 - November 2010
Synteract, Inc.   2008 - 2009
Quintiles  2006 - 2008
Duke University  August 1998 - 2006

Skills
GCP, Clinical Research, Healthcare, Drug Safety, Clinical Trials, Oncology, CRO, Cardiology, EDC, Pharmacovigilance, Medical Devices, Research, Protocol, Sop, Nursing, Cancer, ICH-GCP, CTMS, Clinical Data Management, Clinical Development, Clinical Monitoring, FDA, Medicine, Pharmaceutical Industry, Regulatory Requirements, Therapeutic Areas, SOP

Education
North Carolina Agricultural and Technical State University
BS, Nursing

Jeri O'Dowd Jeri O'Dowd New Bern, North Carolina Details
Jeri O'Dowd's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience January 2011 - March 2012
Job Sr. Clinical Team Manager, Clinical Research Professional, RN, MS Student (CAM), Yoga teacher
Industry Pharmaceuticals
Experience
ICON plc  August 2013 - Present
UCB Pharma  2012 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   January 2011 - March 2012
PPD  2001 - December 2010

Skills
Alternative Medicine, Yoga, Clinical Research, Oncology, CRO, CTMS, Clinical Development, Clinical Monitoring, Clinical Trials, Diabetes, EDC, Holistic Health, Medicine, Nutrition, Wellness

Education
American College of Health Care Sciences   2010 — 2014
MS-CAM, Complementary Alternative Medicine

East Carolina University
BSN, Nursing

Kirsten Topps Kirsten Topps Raleigh-Durham, North Carolina Area Details
Kirsten Topps's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience October 2007 - December 2010
Job Senior Patient Recruitment Manager at inVentiv Health
Industry Pharmaceuticals
Experience
inVentiv Health  August 2014 - Present
Quintiles Transnational  January 2011 - August 2014
Quintiles Transnational  January 2011 - February 2012
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   October 2007 - December 2010
Resolvit  February 2007 - October 2007

Skills
CRO, CTMS, Clinical Research, Clinical Trials, Digital Strategy, GCP, ICH-GCP

Education
East Carolina University   1994 — 1999
BS & MS, Child Development and Family Relations

Yiota Loukas Yiota Loukas Raleigh-Durham, North Carolina Area Details
Yiota Loukas's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience September 2010 - Present
Job Lead Clinical Data Manager at Novella Clinical, Inc. "formerly known as PharmaLinkFHI"
Industry Pharmaceuticals
Experience
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   September 2010 - Present
PPD  August 2004 - December 2010
Integrated Pharma Services (IPS)   August 2001 - May 2004
Pfizer  January 2000 - May 2000
LabCorp  February 1996 - July 1996

Skills
Clinical Trials, Rheumatoid Arthritis, Hypertension, Osteoporosis, EDC, CRO, Clinical Data Management, GCP, CTMS, Oracle Clinical, ICH-GCP, Breast Cancer, Inform, Clinical Development, Oncology, Clinical Research

Education
University of North Carolina at Chapel Hill
Bachelor of Applied Science (B.A.Sc.), Biology

Lauren Hartmann Lauren Hartmann Portland, Oregon Area Details
Lauren Hartmann's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience 2005 - 2011
Job
Industry Pharmaceuticals
Experience
MoonRidge Clinical Consulting   January 2000 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   2005 - 2011
Stamm Consulting   November 1994 - December 1999

Skills
Oncology, Clinical Development, CTMS, Clinical Research, GCP, Pharmaceutical Industry, Therapeutic Areas, Project Management, CRO, Clinical Trials, Cell, EDC, Osteoporosis, Clinical Monitoring

Education
University of Phoenix   1989 — 1991
BSN, Nursing

University of Colorado Anschutz Medical Campus   1984 — 1985
Certificate, Womens' Health Care Nurse Practitioner

University of Nebraska-Lincoln   1978 — 1980
ADN, Nursing

Randal Hamilton Randal Hamilton Raleigh-Durham, North Carolina Area Details
Randal Hamilton's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience December 2010 - April 2011
Job Communications Consultant
Industry Writing and Editing
Experience
Consulting  January 2007 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   December 2010 - April 2011
GlaxoSmithKline  October 2009 - April 2010
The Durham News   March 2009 - August 2009
GlaxoSmithKline  March 2007 - February 2008
[Personal Time Away from Work]   June 2005 - April 2007
GlaxoSmithKline  June 2001 - June 2005
GlaxoSmithKline  June 2001 - June 2005

Skills
Strategic Communications, Internal Communications, Pharmaceutical Industry, Change Management, Strategic Planning, Crisis Communications, Corporate Communications, Communications Planning, Program Management, Therapeutic Areas, Software Documentation, Technical Writing, Leadership, Strategy, Cross-functional Team...

Education
North Carolina State University
BA

The College of William and Mary
MA

Tricia Brady Tricia Brady Phoenix, Arizona Details
Tricia Brady's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience March 2009 - May 2011
Job Independent Clinical Research Associate at Hapa Consulting Inc
Industry Pharmaceuticals
Experience
Hapa Consulting Inc   April 2011 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   March 2009 - May 2011
Prologue Research  January 2005 - January 2009
PRA International  2003 - 2004

Skills
EDC, Oncology, Inform, Clinical Monitoring, CTMS, Clinical Data Management

Education
Southwest Baptist University   1993 — 1998
Bachelor of Science (BS), Biology, General

Southwest Baptist University
Master of Science (MS), Health/Health Care Administration/Management

Blythe Strickland Blythe Strickland Raleigh-Durham, North Carolina Area Details
Blythe Strickland's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience October 2007 - June 2009
Job Clinical Nurse II NSICU at UNC Health Care
Industry Hospital & Health Care
Experience
UNC Health Care  August 2013 - Present
UCB  November 2010 - July 2013
UNC Health Care  June 2009 - November 2010
Duke University Medical Center  October 2005 - March 2010
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   October 2007 - June 2009
Quintiles  November 2006 - October 2007
Hospital of the University of Pennsylvania  July 2004 - October 2005

Skills
Clinical Trials, Clinical Research, Clinical Monitoring, GCP, Medicine, Oncology, Clinical Data Management, ICH-GCP, Cardiology, Clinical Development, Therapeutic Areas, Pharmaceutical Industry, Infectious Diseases, Regulatory Submissions, Biotechnology, Medical Devices, Inform, Lifesciences

Education
Georgetown University   2015 — 2017
MSN, Acute Care Nurse Practitioner

Cedar Crest College   2000 — 2004
BS, Nursing

Anne Gerald Anne Gerald Raleigh-Durham, North Carolina Area Details
Anne Gerald's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience September 2007 - November 2011
Job Sr. CRA at Worldwide Clinical Trials, Inc.
Industry Research
Experience
Worldwide Clinical Trials, Inc.   December 2011 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   September 2007 - November 2011
Novella Clinical  2007 - November 2011
PharmaLinkFHI  March 2008 - January 2009

Skills
GCP, Clinical Trials, Oncology, Clinical Research, CTMS

Education
University of North Carolina at Wilmington   1984 — 1990
BA, Psychology

Whiteville High School   1980 — 1984

Stan Patterson Stan Patterson Raleigh-Durham, North Carolina Area Details
Stan Patterson's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience September 2008 - April 2011
Job Vice President, Data Operations at Novella Clinical
Industry Pharmaceuticals
Experience
Novella Clinical, Inc.   June 2010 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   September 2008 - April 2011
PharmaLinkFHI (now Novella Clinical)   April 2006 - September 2008

Education
Millsaps College   1986 — 1990

Jeremy Helgevold Jeremy Helgevold Raleigh-Durham, North Carolina Area Details
Jeremy Helgevold's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience January 2010 - August 2010
Job Lead Configuration Analyst at Bracket
Industry Pharmaceuticals
Experience
Bracket  January 2012 - Present
United BioSource Corporation  August 2010 - January 2012
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   January 2010 - August 2010
Clinsys Clinical Research  May 2008 - January 2010
INC Research  May 2004 - April 2008
INC Research  June 2003 - April 2004

Skills
Oracle Clinical, Clinical Trials, Clinical Research, EDC, Medidata, SAS, Clinical Data Management, Microsoft Office, CRO, Data Management, CDISC

Education
North Carolina State University   1999 — 2013
Bachelor's degree, Computer Science

North Carolina State University   1999 — 2003
Bachelor of Science (BS), Computer Science

chong vang chong vang Raleigh-Durham, North Carolina Area Details
chong vang's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience July 2009 - Present
Job Network Engineer
Industry Information Technology and Services
Experience
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   July 2009 - Present

Skills
Software Documentation, Active Directory, Troubleshooting, Cisco Technologies, VPN

Education
North Carolina State University   1995 — 1999
B.S., Microbiology

Jeanne Kokes Jeanne Kokes Eugene, Oregon Area Details
Jeanne Kokes's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience February 2009 - December 2010
Job Nanny in Texas
Industry Pharmaceuticals
Experience
Self-Employed  January 2011 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   February 2009 - December 2010
Kokes Research Consulting, LLC   1996 - 2009

Education
California State University, Fresno   1975 — 1978
BSN, nursing

Lora Royce Lora Royce Woodstock, Georgia Details
Lora Royce's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience September 2009 - February 2010
Job Retired from Clinical Research
Industry Research
Experience
from Clinical Research   April 2010 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   September 2009 - February 2010
i3 Research  October 2004 - June 2008
i3 Research  July 2004 - October 2004
Mylan Bertek Pharmaceuticals  2002 - 2003
InSite Clinical Trials  1996 - 1997
Centrex Laboratories/ St Lukes Hospital   August 1972 - September 1996

Skills
Clinical Trials, Regulatory Affairs, Clinical Research, Oracle Clinical, Management, Project Management, Drug Safety, GCP, Clinical Research..., CRO, CTMS, Clinical Development, Regulatory Submissions, ICH-GCP, EDC, FDA, Pharmaceutical Industry, Sop, Clinical Monitoring, Oncology, Infectious Diseases

Education
Wake Technical Community College   2009 — 2009
Career Latticing Series

State University of New York College at Buffalo   1964 — 1968
BS, Medical Technology

Cara Ramsey Cara Ramsey Greater Denver Area Details
Cara Ramsey's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience November 2009 - September 2012
Job Trial Manager, Integrated Clinical Programs
Industry Biotechnology
Experience
ReSearch Pharmaceutical Services  April 2014 - Present
Novella Clinical, Inc.   September 2012 - April 2014
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   November 2009 - September 2012
Cadence Pharmaceuticals  June 2005 - September 2009
Cadence Pharmaceuticals  January 2007 - February 2009
Cadence Pharmaceuticals  June 2005 - January 2007
Biogen Idec  August 2004 - June 2005
Neurocrine Biosciences  September 2002 - August 2004
Quintiles  February 2002 - September 2002
Quintiles  May 2000 - February 2002

Skills
Clinical Trials, CTMS, Clinical Development, Budgets, CRO, GCP, Clinical Monitoring, EDC, Clinical Research

Education
Kansas State University   1995 — 1997
BS Dietetics

The University of Kansas   1993 — 1995

Vrindar Wells Vrindar Wells Danville, Virginia Area Details
Vrindar Wells's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience 2008 - 2010
Job Senior Clinical Research Associate at Docs Global
Industry Pharmaceuticals
Experience
Docs Global  October 2012 - August 2013
PRA International  May 2011 - August 2012
CRA Consultant   January 2011 - May 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   2008 - 2010
Merz Pharmaceuticals  March 2007 - July 2008
MDS Pharma Services  April 2006 - March 2007
Monitoring Force USA, Inc.   June 2003 - October 2005
PPD  September 2002 - 2003
Quintiles  1998 - September 2002
George Washington University Medical Center  1997 - 1998

Education
George Mason University   1985 — 1996
BS, Biology

Eastbury Comprehensive School-+
BS Biology; Ordinary/Advanced Level Exams - Oxford, Cambridge, London Universities, Chemistry, Biology, Physics, Maths, RE, English Language, English Literature, Sociology, Geography

Mary Lou Cornwall Mary Lou Cornwall Morrisville, North Carolina Details
Mary Lou Cornwall's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience December 2007 - Present
Job Clinical Data Specialist at Novella Clinical, Inc.
Industry Pharmaceuticals
Experience
Novella Clinical, Inc.   November 2014 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   December 2007 - Present
Novella Clinical, Inc.   December 2010 - April 2013
Cary Psychiatry   March 2007 - December 2007
South East Regional Authority   2002 - 2007

Skills
CRO, EDC, CTMS, Security, Software Documentation, Customer Service, Customer Support, Active Directory, Exchange 2010/2007/2003, Knowledge Base, Remedy Ticketing System, Track-It, Oracle Clinical, Protocol, Clinical Data Management, Clinical Development, Clinical Trials

Education
DeVry Institute of Technology   1983 — 1985
Computer Science and Programming, Computer Science

College of Trades and Technology   1980 — 1981
Clerk Typist Diploma

April Clayton April Clayton Raleigh-Durham, North Carolina Area Details
April Clayton's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience 2000 - 2006
Job Associate Director, Early Phase Oncology,Novella Clinical, Inc.
Industry Pharmaceuticals
Experience
Novella Clinical  March 2010 - Present
Omnicare Clinical Research  October 2006 - March 2010
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   2000 - 2006

Education
East Carolina University   1991 — 1994
Bachelor, Health Information Management

Louisburg College   1989 — 1991
Associates

Whitney Loudermilk Whitney Loudermilk Raleigh-Durham, North Carolina Area Details
Whitney Loudermilk's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience August 2006 - July 2007
Job Benefits Specialist at FHI 360
Industry Nonprofit Organization Management
Experience
FHI 360  October 2014 - Present
FHI 360  April 2012 - Present
FHI 360  January 2010 - April 2012
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   August 2006 - July 2007

Skills
Human Resources, Onboarding, HRIS, Performance Management, HR Policies, Training, Personnel Management, Nonprofits, Taleo

Education
Southeastern Baptist Theological Seminary   2007 — 2011
Biblical Counseling

Appalachian State University   2002 — 2006
BS, Psychology

Laura Bonfiglio Laura Bonfiglio Raleigh-Durham, North Carolina Area Details
Laura Bonfiglio's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience 2010 - 2010
Job Independent Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   2010 - 2010
GTC Biotherapeutics  1996 - 2008
Genzyme  1992 - 2001

Skills
Clinical Trials, GCP, Biotechnology, Clinical Development, Drug Development, Pharmaceutical Industry, FDA, Clinical Research, CRO

Education
Duke University, NC   2010 — 2010
Certificate in Legal Nurse Consutling, Medical Malpractice & Pharmaceutical Litigation, No grade given; LNC Certificate

Roosevelt Hospital School of Nurse Anesthesia   1974 — 1976
Certified Registered Nurse Anesthetist, Clinical Anesthesia

University of Miami - School of Nursing   1964 — 1968
BSN, Registered Nursing/Registered Nurse

Duke University
Certificate, Legal Nurse Consulting

Carol Olah Carol Olah Columbus, Ohio Area Details
Carol Olah's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience April 2007 - Present
Job Critical Document Assistant
Industry Pharmaceuticals
Experience
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   April 2007 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   2007 - Present

Education
The Ohio State University   1992 — 1994

The Ohio State University   1985 — 1986

Dave Ransopher Dave Ransopher Greater Salt Lake City Area Details
Dave Ransopher's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience 2000 - 2001
Job
Industry Computer Software
Experience
arrowpoin solution inc   2007 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   2000 - 2001

Education
Hardin-Simmons University   1988 — 1997
computer's engineering, computer scientist

Weber State University   1988 — 1989
enginner, enginnering

Natalie Proffer Natalie Proffer Raleigh-Durham, North Carolina Area Details
Natalie Proffer's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience December 2008 - May 2011
Job Clinical Operations Leader at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL  June 2011 - Present
PAREXEL  June 2011 - Present
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   December 2008 - May 2011

Skills
GCP, CRO, Oncology, CTMS, Clinical Data Management, Clinical Trials, Clinical Development, Inform, EDC, Clinical Monitoring, Sop, ICH-GCP, Pharmaceutical Industry, Oracle Clinical

Education
North Carolina State University   2000 — 2004
Bachelor's degree, Biology/Biological Sciences, General

Carla Pruett-DuBois, RN, BSN, MSNed,MHA/HCM Carla Pruett-DuBois, RN, BSN, MSNed,MHA/HCM Raleigh-Durham, North Carolina Area Details
Carla Pruett-DuBois, RN, BSN, MSNed,MHA/HCM's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience December 2007 - March 2010
Job Senior Safety Specialist at INC Research
Industry Pharmaceuticals
Experience
INC Research  2015 - Present
Theorem Clinical Research  November 2014 - July 2015
HealthCare Connexions, a Telerx Company (a wholly owned subsidiary of Merck)   July 2014 - October 2014
HealthCare Connexions, A Telerx Company (wholly owned subsidiary of Merck)   March 2013 - July 2014
PAREXEL  April 2010 - March 2013
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   December 2007 - March 2010
PPD  March 2007 - December 2007
Southeastern Reproductive Health   March 2006 - April 2007
Access Nurses  August 2006 - February 2007
CaroMont Health  October 2000 - July 2006

Skills
Pharmacovigilance, Drug Safety, GCP, Clinical Trials, ICH-GCP, CRO, MedDRA, EDC, Clinical Development, Oncology, Therapeutic Areas, Regulatory Submissions, ARISg, Inform, Medical Affairs, Regulatory Affairs, Infectious Diseases, Drug Development, SAE Reconciliation, Protocol, 21 CFR Part 11, Cardiology, Argus Safety, Regulatory Requirements, Neurology, FDA, Adverse Event Reporting, Hematology, Diabetes, Clinical Operations, Medidata, Endocrinology, Gastroenterology, Biotechnology, Pharmaceutics, Lifesciences, Oracle Clinical, CRF design, Phase I, Pharmacology, Cancer, Oncology Clinical..., IRB, ICH guidelines, Pharmaceutical Industry, Clinical Research, SOP

Education
Western Governors University   2012 — 2014
BSHIT, Health Care Informatics

University of Phoenix   2006 — 2008
MSN,MHA, Nursing, Health Care Administration

University of Phoenix   2005 — 2006
BSN, Nursing

Foothills Nursing Consortium   1996 — 1997
ADN, Nursing

Isothermal Community College   1990 — 1991
LPN, Nursing

sandra spears sandra spears Atlanta, Georgia Details
sandra spears's Novella Clinical, Inc. "formerly known as PharmaLinkFHI" Experience 2009 - 2010
Job Sr. Drug Safety Associate RN with over 20+ years experience in drug safety, regulatory, clinical and manufacturing
Industry Pharmaceuticals
Experience
Covance, Inc.   February 2014 - December 2014
Covance  February 2014 - November 2014
United Therapeutics  April 2013 - August 2013
Onyx Pharmaceuticals  October 2012 - March 2013
Otsuka America Pharmaceutical, Inc.   August 2011 - March 2012
INC Research  March 2010 - July 2011
Novella Clinical, Inc. "formerly known as PharmaLinkFHI"   2009 - 2010

Skills
ICH-GCP, Oncology, Clinical Development, Clinical Trials, Pharmacovigilance, CRO, Pharmaceutics, Protocol, Drug Safety, Regulatory Submissions, FDA, MedDRA, Sop, GCP, Clinical Research, Pharmaceutical Industry, CTMS, Regulatory Affairs, Biotechnology, Clinical Data Management, EDC, Medical Writing, Therapeutic Areas, Clinical Monitoring, Drug Development, Life Sciences, Infectious Diseases, Medical Devices, Medical Affairs, Cardiology, 21 CFR Part 11, Neurology

Education
Albert Einstein Medical Center School of Nursing   1982 — 1984
RN, Nursing

Lincoln University   1972 — 1976
BA, French/Education